Clinical trial · Observational
Transcriptional and Epimetabolic Profile of Breast Carcinoma With Luminal or HER2+ or Locally Advanced Triple-negative Histotype in Patients With/Without Previous Clinical History of Metabolic Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective pilot study of biological specimens aims to identify new prognostic and predictive biomarkers of response to standard therapy for local advanced BC, as well as to identify new targets for the development of immuno- therapeutic protocols. First aim is therefore to expand our knowledge to increase the response to preoperative treatment, intensify treatment patterns, and select patients based on clinical parameters. In this regard, it appears imperative to investigate yet under-investigated factors that might impair the response to standard therapy for local advanced BC including association to metabolic syndrome and analysis of tumoral and stromal features supporting a tumor microenvironment impenetrable to both drugs and immune system cells.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metabolic Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Influence of metabolic syndrome on the achievement of pathological complete response | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients without metabolic syndrome
- description
- Pre/postmenopausal patients diagnosed with breast cancer undergoing NCT and subsequent surgery with long follow-up
- interventionNames
- Procedure: Influence of metabolic syndrome on the achievement of pathological complete response
- label
- Patients with metabolic syndrome
- description
- Pre/postmenopausal patients diagnosed with breast cancer undergoing NCT and subsequent surgery with long follow-up Metabolic syndrome evaluated on the basis of the following criteria: 1. BMI≥30 2. Glycosylated hemoglobin/baseline blood glucose 3. Triglycerides 4. Hypertension 5. Lipid profile
- interventionNames
- Procedure: Influence of metabolic syndrome on the achievement of pathological complete response
Primary outcomes (1)
- measure
- Acheivement of pathological complete response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients will be treated as per standard. Inclusion criteria depend exclusively on compliance with informed consent, tumor size (only advanced stage tumors will be used for the study) and histological diagnosis. Specifically, patients with the following will be included in the proposed study: * Histological diagnosis of locally advanced Luminal or HER2+ or Triple negative breast cancer (cT2, T3, T4 N0 or any T N1, N2, N3, M0), clinical stage II to III disease. * Age \> 18 years * Regular clinical and instrumental follow up * Informed consent form signed by enrolled patients - Availability of information from medical records: 1. pre/post NAC blood chemistry tests: blood count, glycemia/glycosylated hemoglobin, lipid profile (triglycerides, total cholesterol, HDL + LDL cholesterol); 2. BMI; 3. possible therapy with oral hypoglycaemic drugs/insulin; statins; diuretics/antihypertensive drugs; 4. Sex hormone hormonal status (pre- or post-menopause); Exclusion Criteria: * Prior or synchronous history of systemic malignancy. - History of homo- or contralateral breast cancer. * Evidence of metastatic (Stage IV) disease. * Neo-adjuvant treatment with hormonal therapy.
References
Publications (0)
Data not yet available